Primary Solution Set With Universal Spike, Injection Site And Male Luer Lock

• 8 recalls, same reason

  • Terminated Z-1332-2011 FDA Unclassified (pre-2012) ·initiated 16 Nov 2010
  • Terminated Z-1322-2011 FDA Unclassified (pre-2012) ·initiated 16 Nov 2010
  • Terminated Z-1324-2011 FDA Unclassified (pre-2012) ·initiated 16 Nov 2010
  • Terminated Z-1321-2011 FDA Unclassified (pre-2012) ·initiated 16 Nov 2010
  • Terminated Z-1320-2011 FDA Unclassified (pre-2012) ·initiated 16 Nov 2010
  • Terminated Z-1328-2011 FDA Unclassified (pre-2012) ·initiated 16 Nov 2010
  • Terminated Z-1319-2011 FDA Unclassified (pre-2012) ·initiated 16 Nov 2010
  • Terminated Z-1329-2011 FDA Unclassified (pre-2012) ·initiated 16 Nov 2010

  Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products.

• • Terminated Z-1639-2010 FDA Unclassified (pre-2012) ·initiated 20 Oct 2009

  Bond between the spike and needle may leak, break or detach resulting in leakage or spillage of chemotherapeutic agents

510(k) Number

K011336 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• 30 IV Extension Set W/Two Male Luer Locks

  Class II

  FDA 510(k) K882503 Active Cleared 25 Aug 1988

• Churchill Medical Systems Stopcock

  Class II

  FDA 510(k) K012157 Active Cleared 11 Sep 2001

• Cms IV Filters

  Class II

  FDA 510(k) K896333 Active Cleared 11 Jan 1990

• Universal Vial Access Spike with Needleless Connector

  Class II

  FDA 510(k) K013949 Active Cleared 27 Mar 2002

• CMS IV Extension Sets

  Class II

  FDA 510(k) K884370 Active Cleared 7 Nov 1988

• Modification to 30 Extension Set

  Class II

  FDA 510(k) K021395 Active Cleared 13 May 2002

See all devices from Churchill Medical Systems, Inc. →

• What is this device used for?

  This device is designed for the intravenous administration of fluids and medications in general hospital settings. It enables safe and controlled delivery of therapeutic solutions through a sterile fluid path that includes a universal spike for container access, a Y-injection site for medication addition, and a male luer lock for secure connection to IV catheters or extension sets.

• Is this infusion set sterile and single-use?

  Yes, the set is supplied as a sterile, single-use device. It is individually blister-packaged to maintain sterility until point of use and is intended for one-time application only. Reuse is not recommended as it could compromise sterility, increase infection risk, and lead to mechanical failure or cross-contamination.

• What components are included in this primary solution set?

  The set includes a universal spike for piercing IV solution containers, a male swivel luer lock connector for secure attachment to IV catheters, a roller clamp for flow rate control, a drip chamber equipped with a 15 micron filter to remove particulates, and a Y-injection site positioned 6 inches from the distal end for intermittent medication administration without disconnecting the line.

• How is this device packaged and what is its priming volume?

  The infusion set is individually blister-packaged and supplied in boxes of 50 units. Its fluid path primes at 15.58 mL, which is the volume required to fill the tubing and remove air before initiating infusion. This priming volume should be accounted for when administering medications to ensure accurate dosing, especially in low-volume or pediatric cases.

• What is the drop factor of this infusion set?

  The set delivers fluid at a rate of 20 drops per milliliter (20 gtt/mL), which is the drop factor used to calculate infusion rates when using gravity-fed administration. This specification allows clinicians to regulate flow by adjusting the roller clamp and counting drops in the drip chamber, ensuring precise delivery of fluids or medications as prescribed.